SN-38 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple Phase 1, Phase 1/2, and Phase 2 clinical trials evaluate SN-38 and its prodrug or conjugated formulations across various oncology indications, including advanced solid tumors, metastatic triple-negative and HR+/HER2- breast cancers, urothelial carcinoma, colorectal cancer, and lymphoma. Sponsored by organizations such as Gilead Sciences, Enzon Pharmaceuticals, TaiRx Inc., and the National Cancer Institute, these studies encompass recruitment statuses ranging from actively recruiting and active not recruiting to completed and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06986811	RECRUITING	Locally Resectable Paediatric Tumours	CEBIOTEX	2025-05-06	PHASE2
NCT04251416	ACTIVE_NOT_RECRUITING	Endometrial Carcinoma	Yale University	2020-03-17	PHASE2
NCT06123468	COMPLETED	Esophagogastric Adenocarcinoma	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	2024-04-17	PHASE1; PHASE2
NCT04619056	COMPLETED	Locally Advanced Soft Tissue Sarcoma; Recurrent Soft Tissue Sarcoma	CEBIOTEX	2020-06-03	PHASE1
NCT06143774	Recruiting	Advanced Solid Tumor	TaiRx Inc.	2023-10-31	Phase 1
NCT05101096	Recruiting	Advanced Solid Tumor\|Metastatic Triple-Negative Breast Cancer\|HR+/HER2- Metastatic Breast Cancer\|Metastatic Urothelial Cancer	Gilead Sciences	2021-10-20	Phase 1\|Phase 2
NCT05119907	Recruiting	Solid Tumor	Gilead Sciences	2021-10-12	Phase 2
NCT04866641	Recruiting	Advanced Solid Tumor	Taivex Therapeutics Corporation	2021-06-24	Phase 1
NCT04617522	Recruiting	Advanced or Metastatic Solid Tumor\|Liver Failure	Gilead Sciences	2021-04-06	Phase 1
NCT03824899	UNKNOWN	Locally Advanced Rectal Cancer	Fudan University	2018-10-10
NCT01915472	WITHDRAWN	Metastatic Colorectal Cancer	Gilead Sciences	2013-09	PHASE2
NCT01634555	COMPLETED	Solid Tumors	Eli Lilly and Company	2012-10	PHASE2
NCT00931840	UNKNOWN	Metastatic Colorectal Cancer	Enzon Pharmaceuticals, Inc.	2009-06	PHASE2
NCT00311610	COMPLETED	Colorectal Cancer	Alliance for Clinical Trials in Oncology	2006-01	PHASE2
NCT00520390	COMPLETED	Lymphoma; Advanced Solid Tumors	Enzon Pharmaceuticals, Inc.	2007-05	PHASE1
NCT01251926	COMPLETED	Neoplasms	National Cancer Institute (NCI)	2010-11-15	PHASE1
NCT00520637	COMPLETED	Advanced Solid Tumors; Lymphoma	Enzon Pharmaceuticals, Inc.	2007-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-05-31)

Check the SN-38 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SN-38 selectively binds to and inhibits DNA topoisomerase I, preventing the religation of single-stranded DNA breaks during replication to induce double-strand break formation, autophagy, and cell death. This persistent inhibition of DNA synthesis and cellular proliferation underlies its therapeutic efficacy in clinical trials for advanced solid tumors, breast cancers, and colorectal malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).